https://www.avient.com/news/avient-launches-new-bio-based-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2022
Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/news/polyone-expands-pre-certified-biocompatible-healthcare-portfolio
These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols.
All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings.
https://www.avient.com/news/polyone-specialty-tpe-material-enables-oems-meet-skin-sensitivity-testing-requirements
– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation.
Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.
https://www.avient.com/sites/default/files/2021-04/avient-sustain-2019-210419-interactive.pdf
Avient has 78 facilities worldwide certified to the ISO9001 standard.
For our sensitive applications, in addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing Processes (GMP). 100% of our facilities producing those sensitive applications and warehouses are GMP audited within a three-year period.
In 2021, we anticipate formalizing and standardizing our approach to Life Cycle Analysis (LCA) and fully prioritizing the product portfolio in all critical markets/materials. 78 ISO9001 Certified FACILITIES ZERO Major Non-Conformances at ISO Sites HOME | Contents | Message from the CEO | Who We Are | People | Products | Planet | Performance | Goals & Metrics | Indices Sustainability Report | 2019 60Sustainability Report | 2019 60 Supplier Evaluation We seek to collaborate with excellent organizations that espouse our values and principles to bring innovation, sustainable materials and efficient processes to Avient and our customers.
https://www.avient.com/sites/default/files/2020-10/2019-avient-sustainability-report.pdf
Avient has 78 facilities worldwide certified to the ISO9001 standard.
For our sensitive applications, in addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing Processes (GMP). 100% of our facilities producing those sensitive applications and warehouses are GMP audited within a three-year period.
In 2021, we anticipate formalizing and standardizing our approach to Life Cycle Analysis (LCA) and fully prioritizing the product portfolio in all critical markets/materials. 78 ISO9001 Certified FACILITIES ZERO Major Non-Conformances at ISO Sites HOME | Contents | Message from the CEO | Who We Are | People | Products | Planet | Performance | Goals & Metrics | Indices Sustainability Report | 2019 60Sustainability Report | 2019 60 Supplier Evaluation We seek to collaborate with excellent organizations that espouse our values and principles to bring innovation, sustainable materials and efficient processes to Avient and our customers.
https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Locations Scope Norm / Revision Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Avient Colorants USA LLC 17 Foss Rd.
https://www.avient.com/company/policies-and-governance/supplier-code-conduct
Global ISO Certificate Library
https://www.avient.com/knowledge-base/article/regulatory-issues-0
These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.
https://www.avient.com/sites/default/files/2023-10/ISO 22000 Certificate.pdf
Certificate Number: 255 ISO2P Date First Registered: 03/04/2023 Issued on: 11/04/2023 Valid until: 10/04/2026 Awarded to AVIENT PAKISTAN (PVT) LTD 1A/1, Sector#20, Korangi Industrial Area, Sector 20 Karachi, Pakistan In recognition of the Organization´s Food Safety Management System which complies with : ISO 22000:2018 Food Category : I For the scope of activities described below: Manufacturing & Processing of Polymer Resins & Master batch F-3/22/ A 100 Issue date : 06/2022 Version:03 It is mandatory to carry out the surveillance audit on its time.
https://www.avient.com/products/polymer-additives/healthcare-additives/mevopur-healthcare-functional-additives
Global network of ISO 13485 certified manufacturing sites
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission
MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield